Application for derogation for medical devices
- Published: November 3, 2020
- Last updated: March 11, 2025
Manufacturers of medical devices may, following a separate application and under certain conditions, be granted derogation from certain requirements in the medical device regulations, if the purpose is to protect the life and health of the patient/user.
Derogations may be granted for one (1) or a specified number of devices, and only for a limited time period. The derogation will only be valid in Sweden. However, derogations cannot be granted based solely on business reasons or as an alternative to performing clinical evaluation or performance evaluation.
Manufacturers of a national medical information system (NMI) may also, under certain conditions, be exempted from meeting certain requirements in the regulations, see information on a separate website (in Swedish only).
For a derogation to be granted, the following criteria must be fulfilled:
- the use of the product must be justified for reasons relating to public health or the safety or health of patients
- there must be no equivalent alternative medical device(s) on the Swedish market that meet the regulatory requirements
- it must be possible to use the medical device safely, even though the regulatory requirements are not met
- a derogation must not involve an unacceptable benefit-risk balance.
Requirements from which manufacturers may be granted derogation:
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Conformity assessment procedures (CE marking) in the MDR and IVDR. It might be a situation where a device is approved on another market outside of EU/EEA, or if the manufacturer is still within the process of conformity assessment involving a notified body, if such a certificate is required for CE marking.
The provisions that form the basis for derogation from conformity assessment are found in Article 59 of the MDR and Article 54 of the IVDR, respectively.
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Requirements in national legislation that the medical device's user manual, labeling and/or user interface must be in Swedish when the device is provided to users and patients in Sweden (National language requirements). That can be situations where instructions for use, labelling and/or user interfaces will not yet be available in Swedish when the device is placed on the market and taken into use in Sweden.
The provisions that form the basis for exemption from the national language requirement are found in Chapter 3, Section 3 of the Regulation (2021:631) with supplementary provisions to the EU regulations on medical devices.
It is the manufacturer who must show, in their application, that there is a (medical) need for the device, which cannot be accommodated in any other way than through a derogation, and that all criteria are fulfilled.
Two important sections
A basic requirement for a derogation is that both the manufacturer (or the manufacturer’s representative) and a healthcare provider must justify the need of the product(s), for an individual patient or a group of patients. The application is thus divided into two sections, and both must be completed for the application to be considered as complete.
Furthermore, for the application to be considered complete, relevant documentation must also be submitted and, in the case of an application for derogation from CE marking, also invoice information.
Healthcare provider’s justification
Each application must contain a justification of the needs in healthcare for the specific device. The justification shall be based on reasons relating to public health or patient safety or health. To achieve this, the healthcare provider who will be using the device (under derogation) must fill out and sign the healthcare provider´s ("vårdgivaren") part of the application.
The healthcare provider shall explain and justify why the device is needed for a specific patient or within a specified area of operation. Furthermore, any potential consequences for the patients/users, if they would not be given access to the medical device shall be explained. The needs in healthcare cannot be justified by any other aspects than public health or patient needs.
The healthcare provider testifies through their signature that no equivalent CE-marked devices, alternatively other NMI-marked products, are available or that other products/methods are not possible to use for the specific patient(s).
In the case where an application for derogation applies to a product directly aimed for general public ("consumer product") and in other cases where there is no individual designated healthcare provider, the healthcare provider´s part of the application may sometimes be replaced by corresponding information from for example the public health agency of Sweden (Folkhälsomyndigheten) or any other public actor within Swedish healthcare. Even for such products there must be a clear justification that they are needed to protect public health or the safety and health of individuals.
Manufacturer’s justification
The manufacturer (or the manufacturer’s representative) fills out all details in the application in the manufacturer´s part and attaches documentation indicated by the e-service.
Documentation from the manufacturer must provide evidence for that the device, even under derogation, can be used safely. The documentation must also provide evidence of a positive benefit-risk ratio.
Documentation supporting the legal status of the device, for example the EU declaration of conformity (DoC) or equivalent, and any certificates issued by a notified body (for the quality management system or the device) shall always be attached together with the instructions for use and labelling of the device.
Application via e-service
The application is submitted via an e-service.
First, the healthcare provider fills out its part and sends the signed part as well as any attachments to the manufacturer. The manufacturer or its representative then fills out the manufacturer´s part and supplements relevant documentation as well as the healthcare provider´s part and submits it via the e-service to the Swedish Medical Products Agency.
It is recommended to have the information and documents available when starting to fill in information in the e-service, as each part of the application needs to be completed within 60 minutes. It is therefore not advisable to have to search for information or documents while filling out the e-service.
Healthcare provider´s tasks
When the healthcare provider submits its part of the application, the following steps should be completed:
- The healthcare provider fills out its part of the application in the e-service.
- The healthcare provider downloads its part of the application from the last page of the e-service.
- The healthcare provider signs its part (outside the e-service).
- The healthcare provider sends its part and any attachments to the manufacturer, for example via email (outside the e-service).
Information that the healthcare provider must provide in the application for derogation
- Name and postal address of the healthcare provider
- Name and contact details of the healthcare provider's contact person
- Product details
- Name of the product
- Number of patients to be treated with the product and number of product copies needed to treat the patient(s) during the derogation period, including justification for the number
- A description of the medical condition and justification for the need for the product.
- A description of the possible consequences for the patient(s) health if they are not given access to the product.
- A description of the measures that have been taken to find an alternative product that meets the requirements of the regulations.
- Information on whether CE-marked medical devices, alternatively NMI-marked NMI, with the same or similar intended purpose or other possible alternative treatment methods are available in Sweden. If there are any, these shall be stated.
- If alternative products or treatment methods exist, a justification based on the needs of the patient(s) or public health why none of these are suitable for the patient(s).
- If alternative products or treatment methods exist, a description of the transition required to switch to an alternative product/treatment method and how long the transition is expected to take.
- When applying for a derogation from the language requirement: An explanation of how the product, despite not meeting the language requirement, can be used in a safe and appropriate manner for the patient user or, where applicable, other persons.
Documentation that complements the healthcare provider´s information
In some cases, the healthcare provider wishes to attach supplementary documentation with the derogation application. There are two different ways in which this documentation can be submitted, see below.
- The healthcare provider sends the documentation to the manufacturer, who attaches the documentation to their part of the application to the Swedish Medical Products Agency. The documentation is sent to the manufacturer via, for example, email. This cannot be done in the e-service.
- The healthcare provider submits the documentation directly to the Swedish Medical Products Agency. In that case, the applicant must notify this in a text field in the e-service. The responsible assessor will then contact the contact person when the application has been received by the Swedish Medical Products Agency.
Regardless of which route is chosen, the documentation must be accompanied by a list clearly stating what each document/file refers to in order to understand what function the document fulfills in the application.
Manufacturer´s tasks
After the healthcare provider has sent its part of the application, the following steps must be completed:
- The manufacturer fills out its part and attaches relevant information as well as the healthcare provider´s part. Note that it may be necessary to submit several copies of the healthcare provider´s part when several healthcare providers are affected.
- The manufacturer submits the application to the Swedish Medical Products Agency via the e-service.
Information that the manufacturer must provide in the application for derogation
- Name and postal address of the manufacturer.
- Information about the contact person (name, role, address).
- Information about whether the contact person is an authorized signatory for the manufacturer.
- Type of application (new application or extension).
- If it is an extension, the previous case number(s) (Dnr) must be provided
- Reason for the derogation application (CE marking; NMI marking, language requirements)
- When applying for language requirements, a description of the timetable for the translation(s)
- When applying for a derogation from CE marking, information about the product that will be CE marked and information about the timetable for this
- When applying for a derogation from NMI marking, information about the product that will be NMI marked and information about the timetable for this.
- A list of all healthcare providers in need
- Derogation
- A description of the reason for the application for derogation and justification why the derogation is needed.
- A clarification of which specific requirements in the medical device regulations, alternatively the NMI regulations, the derogation application applies to.
- Number of product copies to which the derogation application relates and how many patients are to be treated, including justification.
- Information and justification about where the product is to be used (caregiver/region or equivalent; consumer product).
- The time period for which the derogation application applies and justification for this.
- Information on how any service and maintenance of the product during the derogation period is handled.
- Information on how the derogation product(s) will be handled after the derogation period.
- Billing information (excluding NMI marking and language requirements).
- Name and postal address.
- Organization number.
- Information about the contact person (name, role, address).
- Electronic invoicing.
- Peppol ID or email address for PDF invoice.
- Reference to be stated on the invoice (optional).
- PO number (optional).
- Product information
- Product name.
- Generic name of the product.
- Product EMDN code if available.
- Intended purpose of the product.
- Information on whether the product has been used previously, for example in a clinical trial/performance study or in other markets.
- If the product has been used previously, the number of products released in Sweden during the past year and where should be stated.
- A description of how the product differs from other corresponding medical devices with the same or similar intended purpose or other possible alternative treatment methods available in Sweden
- A justification as to why these cannot be used instead of the product
- Explanation of the documentation provided that supports that the product, despite not meeting the conformity assessment procedures (CE marking/NMI marking)/language requirement, can be used in a safe and appropriate manner for the patient and others involved.
This section shall also include a summary of why the documentation also supports a positive benefit/risk balance during the derogation period.
Documents that the manufacturer must attach to a derogation application
- If the person submitting the derogation application is not the company signatory, a power of attorney that proves that he or she is authorized to submit the derogation application in the manufacturer's name.
- If the person submitting the derogation application is the company signatory, a document that proves that the person is the authorized signatory for the manufacturer.
- The healthcare provider's signed part of the derogation application (completed in the e-service, signed, scanned and saved as a PDF) and any attachments from the healthcare provider. Please note that it may be necessary to submit multiple copies of the healthcare provider's part when several healthcare providers are involved.
- When applying for a derogation from language requirements
- any relevant documents for the translation process.
- When applying for a derogation from CE marking
- a timetable for CE marking
- communication with the notified body about the conformity assessment process.
- When applying for a derogation from NMI marking
- a timetable for NMI marking.
- Documentation that supports that the product has been used previously.
- Documentation supporting the legal status of the product, such as
- EU declaration of conformity (DoC), alternatively declaration of conformity, if applicable
- any (previous) certificates of conformity from notified bodies (quality management certificate and/or product cez
- Documentation supporting that the product can be used in a safe and appropriate manner for the patient and other stakeholders, despite not meeting the conformity assessment procedures (CE marking/NMI marking)/language requirement. The documentation shall also contain information supporting a positive benefit/risk balance during the derogation period. Such documentation may, for example, be a risk management report.
- The product's instructions for use and labeling.
- Any other relevant certificates or other documentation that proves that the product can be used safely even though not all regulatory requirements are met.
Extension of a derogation
If there are strong grounds, an extension in time of an derogation period may be tried following a renewed application. The same application procedure shall be used together with additional documentation justifying the extension. In order to facilitate handling, the manufacturer should refer to the case number ("diarienummer") for the original derogation.
The Swedish Medical Products Agency’s assessment
The assessment made by the Swedish Medical Products Agency regarding granting or rejection of the application for derogation is based on the requirement that all products used in Sweden must be safe and appropriate for use. For a derogation to be granted devices must fulfil the requirements on safety and performance as far as possible.
Often, the Swedish Medical Products Agency needs access to substantial documentation on the device and the manufacturer. Reasons for a decision are always based on patient safety and/or public health. Business reasons are not sufficient for granting a derogation.
When needed, the Swedish Medical Products Agency cooperates with other authorities in Sweden and/or the EU and with the European Commission.
Products on the market under a derogation
A device that has been placed on the market and taken into service after the Swedish Medical Products Agency has granted a derogation may not be sold or transferred to any other healthcare provider(s) or user(s) other than the one(s) specified in the decision.
The manufacturer (or their authorised representative) is also responsible for informing the users about which products that are covered by the derogation and any conditions that apply to the derogation. The Swedish Medical Products Agency states any such conditions in the decision, when warranted.
A "derogation device" that is placed on the market for use by consumers or the general public may have this indicated in different ways, for example through the labelling. Some "derogation devices" may have accompanying information in their packaging, others may have modified CE marking on the device itself or on the packaging.
If you, as a patient or user, have questions relating to if a product is covered by a derogation, you should primarily contact the manufacturer or their authorised representative. Their contact details shall be available on the device’s labelling.
Fees
From January 1st 2022, there is a fee of 62 000 SEK for applications for derogation from one or more requirements for CE marking. There is no fee for applications for derogation from the language requirements.
The fee should be paid by the applicant (that is the manufacturer or their authorised representative) after submitting the application to the Swedish Medical Products Agency. The fee covers costs for case handling, regardless of whether the derogation is granted or rejected.
In order to enable invoicing, invoicing information must be provided with the application.
Reduction of fees
The Swedish Medical Products Agency may, in an individual case, repay or reduce the entire or parts of a fee, if there are specific reasons for this. This can be done when the applicant submits a duly justified application for a reduction of the fee via email to registrator@lakemedelsverket.se, together with a clear reference to the case number ("diarienummer") of the corresponding application for derogation.
Regulatory framework
The requirements from which the Swedish Medical Products Agency may grant derogations are laid down in Article 59 MDR and Article 54 IVDR, respectively.
Derogations from national language requirements are given by SFS 2021:631 for devices under MDR/IVDR and by LVFS 2003:11, LVFS 2001:7 or LVFS 2001:5 for legacy devices.
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Department of Medical devices
Telephone: +46 (0)18-17 46 00
Email: registrator@lakemedelsverket.se